Second Malignant Neoplasms After Childhood ALL Therapy; An International Ponte di Legno Study

Brief Summary

Development of a second neoplasm (SMN) during or after therapy for childhood acute lymphoblastic leukemia (ALL) is a rare event generally associated with a poor prognosis. In this international study we analyze subtypes of SMN in relation to their initial leukemia characteristics and treatment, and their subsequent overall survival.

Detailed Description

To explore epidemiology, potential risk factors and survival rates of second cancers occurring as the first event in childhood acute lymphoblastic leukemia the involved study groups will collect anonymous data on all such cases diagnosed within the last decades to form a common database with predefined variables comprising the clinical, biological, and cytogenetic characteristics (myeloid neoplasias only) as well as outcome. Furthermore, we will register the clinical, biological, and cytogenetic characteristics of the acute lymphoblastic leukemia as well as type of treatment given.

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: Case-OnlyTime Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study cohort includes all registered cases of second cancers occurring as the first event among children diagnosed with acute lymphoblastic leukemia and treated according to protocol by one of the collaborative groups participating in the present study

Condition ICMJE

Acute Lymphoblastic Leukemia

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

ALL diagnosed 1980-2007

Cases of childhood acute lymphoblastic leukemia (ALL) diagnosed between 1980 and 2007 and included in the clinical trials of the participating ALL study groups

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

642

Completion Date

December 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Diagnosed with childhood acute lymphoblastic leukemia

Diagnosis of second cancer before December 31st 2007

Exclusion Criteria:

Uncertainty if the second cancer has emerged from the same original leukemic clone

Gender

Both

Ages

up to 20 Years

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects